FDA Medical Device Recalls (openFDA)
Beta Bionics, Inc.: iLet Bionic Pancreas, REF: BB1001
- Recall number
- Z-1996-2026
- Recalling firm
- Beta Bionics, Inc.
- Product
- iLet Bionic Pancreas, REF: BB1001
- Status
- Open, Classified
- Initiated
- 2026-03-12
- Posted
- 2026-04-29
- Terminated
- not on file
- Reason
- insulin pump software versions 1.4.2, and 1.4.3 issue with Dexcom Continuous Glucose Monitoring (CGM) G7 sensor may result in delayed CGM reading then switch to non-CGM dosing, leading to only basal/requested meal doses provided, no correction doses/insulin reductions/suspensions for high/low glucose unless blood glucose entered for sensor life or replacement. Potential health risks to users include severe hyperglycemia with and without DKA and severe hypoglycemia.
- Root cause
- Software change control
- Action
- On 3/12/2026, correction notices were emailed to customers who were asked to do the following: Update device software to host software 1.4.4 and up. Update your software 1. Download or update your iLet app on your phone. Read the iLet App User Guide: https://www.betabionics.com/wp-content/uploads/LA000056_F-iLet-Mobile-App-User-Guide.pdf 2. Log into your iLet app. 3. Position your iLet next to your phone with the app open. 4. Go to app settings on the iLet app and follow the on-screen instructions to update to the latest firmware. -Distributors are asked to provide patient contact information so the firm can provide the correction notice to these patients. - Complete the acknowledgment survey https://sprw.io/stt-6HnQU If you have any questions, please call the firm's Customer Care at 1-855-745-3800 option 1.
- Quantity
- 1,080
- Distribution
- US Nationwide distribution in the states of TX, PA, AL, MI, OH, FL, TN, GA.
- Lot, serial or model codes
- Software versions 1.4.3, and 1.4.2
- 510(k) numbers
- ["K252770"]
- PMA numbers
- not on file
- Product code
- QFG
- Firm FEI
- 3019004087
- Firm city
- Irvine
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28